Myopia
Conditions
Brief summary
The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.
Detailed description
This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.
Interventions
DEVICEPair 1 (ocufilcon D / ocufilcon D)
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
DEVICEPair 2 (ocufilcon D / enfilcon A)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
DEVICEPair 3 (ocufilcon D / comfilcon A)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
DEVICEPair 4 (methafilcon A / methafilcon A)
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
DEVICEPair 5 (methafilcon A / comfilcon A)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
DEVICEPair 6 (omafilcon A / comfilcon A)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Is between 18 and 40 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted soft contact lens wearer * Has a cl spherical prescription between -1.00 and -6.00 (inclusive) * Has a spectacle cylinder up to 0.75D (diopter) in each eye * Is correctable to a visual acuity of 20/25 or better in both eyes * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter * Is willing to comply with the wear schedule * Is willing to comply with the visit schedule
Exclusion criteria
A person will be excluded from the study if he/she: * Has never worn contact lenses before * Currently wears rigid gas permeable contact lenses * Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day) * Has a contact lens prescription outside the range of -1.00 to -6.00D * Has a spectacle cylinder ≥ 1.00D of cylinder in either eye * Has best corrected spectacle distance vision worse than 20/25 in either eye * Has any systemic or topical medications that will affect ocular health * Has any ocular pathology or severe insufficiency of lacrimal secretion * Has persistent, clinically significant corneal or conjunctival staining * Has active neovascularization or any central corneal scars * Is aphakic * Is presbyopic * Has undergone corneal refractive surgery * Is participating in any other type of eye related conical or research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (VA) logMAR (Habitual Lenses) | Baseline | Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR) |
| Visual Acuity (VA) logMAR (Study Lenses) | Dispense | Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR) |
| Comfort Contact Lens Insertion (Day 1 Study Lenses) | Day 1 - Insertion | Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever) |
| Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | Day 1 - 30 minutes | Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever) |
| Comfort Contact Lens Insertion (Day 2 Study Lenses) | Day 2 - Insertion | Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever |
| Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | Day 2 - 30 minutes | Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever |
| Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1) | Day 1 - Insertion | Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2) | Day 1 Insertion | Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3) | Day 1 - Insertion | Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | Day 1 - 30 minutes | Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | Day 1 - 30 minutes | Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | Day 1 - 30 minutes | Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1) | Day 2 - Insertion | Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2) | Day 2 - Insertion | Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3) | Day 2 - Insertion | Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | Day 2 - 30 minutes | Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) |
| Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | Day 2 - 30 minutes | Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right) |
| Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | Day 2 - 30 minutes | Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right) |
| Lens Fitting Characteristics, Centration (Habitual Lens) | Baseline | Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable) |
| Lens Fitting Characteristics, Tightness (Habitual Lens) | Baseline | Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement) |
| Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens) | Baseline | Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm) |
| Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | Day 1 - 30 minutes | Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable) |
| Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | Day 1 - 30 minutes | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement) |
| Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Day 1 - 30 minutes | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm) |
| Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | Day 2 - 30 minutes | Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable) |
| Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | Day 2 - 30 minutes | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement) |
| Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Day 2 - 30 minutes | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm) |
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | Day 1- 30 minutes | Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) |
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | Day 1- 30 minutes | Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) |
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | Day 1 - 30 minutes | Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) |
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | Day 2 - Insertion | Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) |
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | Day 2 - Insertion | Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) |
| Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | Day 2 - Insertion | Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) |
| Overall Ease of Lens Handling (Day 1 Study Lenses) | Day 1 - After Removal | Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy |
| Overall Ease of Lens Handling (Day 2 Study Lenses) | Day 2 - After Removal | Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Group All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Overall Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race/Ethnicity, Customized Asian | 10 participants |
| Race/Ethnicity, Customized Non-Asian | 10 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)
Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | 97 units on a scale | Standard Deviation 1.8 |
| B55 SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | 96 units on a scale | Standard Deviation 1.3 |
| BF SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | 96 units on a scale | Standard Deviation 1.6 |
| AV SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | 96 units on a scale | Standard Deviation 1.1 |
| PCM SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | 96 units on a scale | Standard Deviation 1.8 |
| F55 SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | 95 units on a scale | Standard Deviation 1.3 |
Primary
Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)
Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever
Time frame: Day 2 - 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | 96 units on a scale | Standard Deviation 6 |
| B55 SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | 93 units on a scale | Standard Deviation 13 |
| BF SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | 94 units on a scale | Standard Deviation 10 |
| AV SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | 96 units on a scale | Standard Deviation 6 |
| PCM SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | 97 units on a scale | Standard Deviation 7 |
| F55 SPHERE LENS | Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | 98 units on a scale | Standard Deviation 3 |
Primary
Comfort Contact Lens Insertion (Day 1 Study Lenses)
Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)
Time frame: Day 1 - Insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Comfort Contact Lens Insertion (Day 1 Study Lenses) | 92 units on a scale | Standard Deviation 8 |
| B55 SPHERE LENS | Comfort Contact Lens Insertion (Day 1 Study Lenses) | 95 units on a scale | Standard Deviation 6 |
| BF SPHERE LENS | Comfort Contact Lens Insertion (Day 1 Study Lenses) | 95 units on a scale | Standard Deviation 7 |
| AV SPHERE LENS | Comfort Contact Lens Insertion (Day 1 Study Lenses) | 97 units on a scale | Standard Deviation 5 |
| PCM SPHERE LENS | Comfort Contact Lens Insertion (Day 1 Study Lenses) | 95 units on a scale | Standard Deviation 8 |
| F55 SPHERE LENS | Comfort Contact Lens Insertion (Day 1 Study Lenses) | 96 units on a scale | Standard Deviation 6 |
Primary
Comfort Contact Lens Insertion (Day 2 Study Lenses)
Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever
Time frame: Day 2 - Insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Comfort Contact Lens Insertion (Day 2 Study Lenses) | 94 units on a scale | Standard Deviation 14 |
| B55 SPHERE LENS | Comfort Contact Lens Insertion (Day 2 Study Lenses) | 92 units on a scale | Standard Deviation 16 |
| BF SPHERE LENS | Comfort Contact Lens Insertion (Day 2 Study Lenses) | 93 units on a scale | Standard Deviation 14 |
| AV SPHERE LENS | Comfort Contact Lens Insertion (Day 2 Study Lenses) | 96 units on a scale | Standard Deviation 8 |
| PCM SPHERE LENS | Comfort Contact Lens Insertion (Day 2 Study Lenses) | 94 units on a scale | Standard Deviation 10 |
| F55 SPHERE LENS | Comfort Contact Lens Insertion (Day 2 Study Lenses) | 97 units on a scale | Standard Deviation 9 |
Primary
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | B55 SPHERE LENS P1 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | B55 PREMIER ASPHERE LENS P1 | 5 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | No Preference | 85 percentage of participants |
Primary
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | B55 SPHERE LENS P2 | 0 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | AV SPHERE LENS P2 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | No Preference | 90 percentage of participants |
Primary
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | B55 SPHERE LENS P3 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | BF SPHERE LENS P3 | 5 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | No Preference | 85 percentage of participants |
Primary
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 2 - 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | No Preference | 75 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | F55 SPHERE LENS P1 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | F55 PREMIER ASPHERE LENS P1 | 15 percentage of participants |
Primary
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)
Time frame: Day 2 - 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | F55 SPHERE LENS P2 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | BIOFINITY LENS P2 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | No Preference | 80 percentage of participants |
Primary
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)
Time frame: Day 2 - 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | PCM SPHERE LENS P3 | 0 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | BF SPHERE LENS P3 | 20 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | No Preference | 80 percentage of participants |
Primary
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)
Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 1 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1) | B55 SPHERE LENS P1 | 5 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1) | B55 PREMIER ASPHERE LENS P1 | 35 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1) | No Preference | 60 percentage of participants |
Primary
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)
Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 1 Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2) | B55 SPHERE LENS P2 | 0 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2) | AV SPHERE LENS P2 | 15 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2) | No Preference | 85 percentage of participants |
Primary
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 1 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3) | B55 SPHERE LENS P3 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3) | BF SPHERE LENS P3 | 20 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3) | No Preference | 70 percentage of participants |
Primary
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)
Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 2 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1) | F55 SPHERE LENS P1 | 20 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1) | F55 PREMIER ASPHERE LENS P1 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1) | No Preference | 70 percentage of participants |
Primary
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)
Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 2 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2) | F55 SPHERE LENS P2 | 10 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2) | BIOFINITY LENS P2 | 15 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2) | No Preference | 75 percentage of participants |
Primary
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)
Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Time frame: Day 2 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3) | PCM SPHERE LENS P3 | 5 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3) | BF SPHERE LENS P3 | 15 percentage of participants |
| Habitual Lens | Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3) | No Preference | 80 percentage of participants |
Primary
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Time frame: Day 1- 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | No Preference | 85 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | B55 SPHERE LENS P1 | 5 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | B55 PREMIER ASPHERE LENS P1 | 10 percentage of investigators |
Primary
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Time frame: Day 1- 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | B55 SPHERE LENS P2 | 15 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | AV SPHERE LENS P2 | 5 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | No Preference | 80 percentage of investigators |
Primary
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | B55 SPHERE LENS P3 | 5 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | BF SPHERE LENS P3 | 10 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | No Preference | 85 percentage of investigators |
Primary
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Time frame: Day 2 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | F55 SPHERE LENS P1 | 5 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | F55 PREMIER ASPHERE LENS P1 | 5 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | No Preference | 90 percentage of investigators |
Primary
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Time frame: Day 2 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | F55 SPHERE LENS P2 | 10 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | BIOFINITY LENS P2 | 40 percentage of investigators |
| Habitual Lens | Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | No Preference | 50 percentage of investigators |
Primary
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Time frame: Day 2 - Insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens | Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | PCM SPHERE LENS P3 | 5 percentage of investigators |
| Habitual Lens | Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | BF SPHERE LENS P3 | 35 percentage of investigators |
| Habitual Lens | Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | No Preference | 60 percentage of investigators |
Primary
Lens Fitting Characteristics, Centration (Day 1 Study Lenses)
Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | 100 percentage of lenses |
| B55 SPHERE LENS | Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | 100 percentage of lenses |
| BF SPHERE LENS | Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | 100 percentage of lenses |
| AV SPHERE LENS | Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | 100 percentage of lenses |
| PCM SPHERE LENS | Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | 100 percentage of lenses |
| F55 SPHERE LENS | Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | 90 percentage of lenses |
Primary
Lens Fitting Characteristics, Centration (Day 2 Study Lenses)
Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Time frame: Day 2 - 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | 95 percentage of lenses |
| B55 SPHERE LENS | Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | 95 percentage of lenses |
| BF SPHERE LENS | Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | 95 percentage of lenses |
| AV SPHERE LENS | Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | 100 percentage of lenses |
| PCM SPHERE LENS | Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | 100 percentage of lenses |
| F55 SPHERE LENS | Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | 100 percentage of lenses |
Primary
Lens Fitting Characteristics, Centration (Habitual Lens)
Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Centration (Habitual Lens) | 75 percentage of eyes |
Primary
Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | 50 percentage | Standard Deviation 13 |
| B55 SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | 48 percentage | Standard Deviation 13 |
| BF SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | 51 percentage | Standard Deviation 13 |
| AV SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | 45 percentage | Standard Deviation 11 |
| PCM SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | 52 percentage | Standard Deviation 16 |
| F55 SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | 54 percentage | Standard Deviation 11 |
Primary
Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Time frame: Day 2 - 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | 53 percentage | Standard Deviation 13.4 |
| B55 SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | 50 percentage | Standard Deviation 14.9 |
| BF SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | 51 percentage | Standard Deviation 13.5 |
| AV SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | 53 percentage | Standard Deviation 12.3 |
| PCM SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | 53 percentage | Standard Deviation 15.2 |
| F55 SPHERE LENS | Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | 55 percentage | Standard Deviation 11.7 |
Primary
Lens Fitting Characteristics, Tightness (Habitual Lens)
Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Tightness (Habitual Lens) | 46 percentage | Standard Deviation 11 |
Primary
Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)
Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens) | Upgaze Lag | 0.21 millimeters | Standard Deviation 0.51 |
| Habitual Lens | Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens) | Post-blink Movement | 0.19 millimeters | Standard Deviation 0.12 |
Primary
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)
Time frame: Day 1 - 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Upper Gaze Lag | 0.00 millimeter | Standard Deviation 0 |
| Habitual Lens | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Post-blink Movement | 0.39 millimeter | Standard Deviation 0.43 |
| B55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Upper Gaze Lag | 0.00 millimeter | Standard Deviation 0 |
| B55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Post-blink Movement | 0.39 millimeter | Standard Deviation 0.4 |
| BF SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Upper Gaze Lag | 0.00 millimeter | Standard Deviation 0 |
| BF SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Post-blink Movement | 0.28 millimeter | Standard Deviation 0.29 |
| AV SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Upper Gaze Lag | 0.05 millimeter | Standard Deviation 0.22 |
| AV SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Post-blink Movement | 0.41 millimeter | Standard Deviation 0.28 |
| PCM SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Upper Gaze Lag | 0.00 millimeter | Standard Deviation 0 |
| PCM SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Post-blink Movement | 0.27 millimeter | Standard Deviation 0.27 |
| F55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Upper Gaze Lag | 0.00 millimeter | Standard Deviation 0 |
| F55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Post-blink Movement | 0.30 millimeter | Standard Deviation 0.25 |
Primary
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)
Time frame: Day 2 - 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Upper Gaze Lag | 0.11 millimeters | Standard Deviation 0.45 |
| Habitual Lens | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Post-blink Movement | 0.32 millimeters | Standard Deviation 0.25 |
| B55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Upper Gaze Lag | 0.14 millimeters | Standard Deviation 0.45 |
| B55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Post-blink Movement | 0.33 millimeters | Standard Deviation 0.22 |
| BF SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Upper Gaze Lag | 0.13 millimeters | Standard Deviation 0.38 |
| BF SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Post-blink Movement | 0.31 millimeters | Standard Deviation 0.35 |
| AV SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Upper Gaze Lag | 0.05 millimeters | Standard Deviation 0.16 |
| AV SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Post-blink Movement | 0.23 millimeters | Standard Deviation 0.21 |
| PCM SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Upper Gaze Lag | 0.33 millimeters | Standard Deviation 0.73 |
| PCM SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Post-blink Movement | 0.39 millimeters | Standard Deviation 0.42 |
| F55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Upper Gaze Lag | 0.00 millimeters | Standard Deviation 0 |
| F55 SPHERE LENS | Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Post-blink Movement | 0.25 millimeters | Standard Deviation 0.2 |
Primary
Overall Ease of Lens Handling (Day 1 Study Lenses)
Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy
Time frame: Day 1 - After Removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Overall Ease of Lens Handling (Day 1 Study Lenses) | 95 units on a scale | Standard Deviation 10 |
| B55 SPHERE LENS | Overall Ease of Lens Handling (Day 1 Study Lenses) | 95 units on a scale | Standard Deviation 10 |
| BF SPHERE LENS | Overall Ease of Lens Handling (Day 1 Study Lenses) | 95 units on a scale | Standard Deviation 10 |
| AV SPHERE LENS | Overall Ease of Lens Handling (Day 1 Study Lenses) | 93 units on a scale | Standard Deviation 12 |
| PCM SPHERE LENS | Overall Ease of Lens Handling (Day 1 Study Lenses) | 94 units on a scale | Standard Deviation 9.3 |
| F55 SPHERE LENS | Overall Ease of Lens Handling (Day 1 Study Lenses) | 92 units on a scale | Standard Deviation 15.4 |
Primary
Overall Ease of Lens Handling (Day 2 Study Lenses)
Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy
Time frame: Day 2 - After Removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Overall Ease of Lens Handling (Day 2 Study Lenses) | 96 units on a scale | Standard Deviation 7.6 |
| B55 SPHERE LENS | Overall Ease of Lens Handling (Day 2 Study Lenses) | 96 units on a scale | Standard Deviation 8.1 |
| BF SPHERE LENS | Overall Ease of Lens Handling (Day 2 Study Lenses) | 96 units on a scale | Standard Deviation 9.8 |
| AV SPHERE LENS | Overall Ease of Lens Handling (Day 2 Study Lenses) | 94 units on a scale | Standard Deviation 12 |
| PCM SPHERE LENS | Overall Ease of Lens Handling (Day 2 Study Lenses) | 94 units on a scale | Standard Deviation 16 |
| F55 SPHERE LENS | Overall Ease of Lens Handling (Day 2 Study Lenses) | 94 units on a scale | Standard Deviation 16 |
Primary
Visual Acuity (VA) logMAR (Habitual Lenses)
Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Visual Acuity (VA) logMAR (Habitual Lenses) | -0.06 LogMar | Standard Deviation 0.08 |
Primary
Visual Acuity (VA) logMAR (Study Lenses)
Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens | Visual Acuity (VA) logMAR (Study Lenses) | -0.13 LogMAR | Standard Deviation 0.06 |
| B55 SPHERE LENS | Visual Acuity (VA) logMAR (Study Lenses) | -0.11 LogMAR | Standard Deviation 0.07 |
| BF SPHERE LENS | Visual Acuity (VA) logMAR (Study Lenses) | -0.13 LogMAR | Standard Deviation 0.06 |
| AV SPHERE LENS | Visual Acuity (VA) logMAR (Study Lenses) | -0.12 LogMAR | Standard Deviation 0.06 |
| PCM SPHERE LENS | Visual Acuity (VA) logMAR (Study Lenses) | -0.13 LogMAR | Standard Deviation 0.07 |
| F55 SPHERE LENS | Visual Acuity (VA) logMAR (Study Lenses) | -0.11 LogMAR | Standard Deviation 0.08 |
| F55 ASPHERE LENS | Visual Acuity (VA) logMAR (Study Lenses) | -0.13 LogMAR | Standard Deviation 0.07 |